Following prior bans reported by CHS [EU And Canada Flu Vaccine Ban – Not Reported By Press] UK’s drug regulator the MHRA yesterday issued an announcement which includes the following:
At the request of MHRA, Novartis Vaccines and Diagnostics S.r.l. is executing a precautionary recall of the above batches. This is due to the presence, in one of the components, of visible protein aggregates that were identified following additional testing during the course of an investigation. Such protein aggregation can occur in influenza vaccines. The aggregation consists mostly of viral proteins expected in the vaccine, and when observed, aggregation is transient and disappears upon shaking as recommended in product labelling. No visible protein aggregates were detected at the time of product release in any of these UK batches.
Based on the information available, there is no evidence of any new safety concerns or of any impact on efficacy. No adverse reactions which may be associated with this issue have been reported to Novartis in connection with these batches. Those who have had a flu vaccine from these batches should have no cause for concern and there is no need for revaccination.
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